How Ayurvedic Products Are Regulated: India, United States, Europe and Elsewhere

Why the rules matter to you

"Ayurvedic" on a bottle is not a legal category with one worldwide meaning. The same herb mix can be a licensed medicine in one country, a dietary supplement in another and an unauthorized product in a third. What a label tells you depends on where you are. This page describes what we read from regulators and public health bodies, with the date we read them (2026-10-22). Laws change, so check your national regulator for the current rules.

The picture at a glance

India

In India the Drugs and Cosmetics Act, 1940 and its Rules, 1945 apply to Ayurveda, Siddha and Unani medicines. The Ministry of Ayush says enforcement of quality control and licensing is vested with State Drug Controllers and State Licensing Authorities. [1] Rule 158-B covers licences to manufacture these medicines, and manufacturers must follow Good Manufacturing Practices under Schedule T and pharmacopoeial quality standards. [1] See the Ayurvedic Pharmacopoeia of India and quality standards. India also runs a pharmacovigilance programme for Ayurveda, Siddha and Unani drugs. [6] The Institute of Teaching and Research in Ayurveda says most reported adverse events with herbal and traditional products are attributed to poor product quality or improper use. [6]

United States

The FDA regulates dietary supplements under a different set of rules than foods and drugs. Manufacturers and distributors are prohibited from marketing adulterated or misbranded supplements, and the FDA has authority to act against them after a product reaches the market. [7] The FDA says it does not approve dietary supplements before they are sold. [2] Independent testing has found problems. A study of 193 Ayurvedic medicines bought on the internet in 2005 found 20.7% contained detectable lead, mercury or arsenic, with similar rates in US-made and India-made products. [8] Rasa shastra products (herbs combined with metals) had metals more often (40.6% versus 17.1%). [8]

For practitioners, NCCIH says there is no significant regulation of Ayurvedic practice or education in the United States, and no state requires a practitioner to have a license. [9] See choosing an Ayurvedic practitioner.

United Kingdom and European Union

In the UK, a traditional herbal medicine must have a traditional herbal registration (THR) before it can be marketed. [3] A THR is only granted for minor conditions that do not need medical supervision, and the applicant must show traditional use for the stated condition for at least 30 years. [3] In the EU, a simplified registration route for traditional herbal medicines was introduced in 2004 through Directive 2004/24/EC, while most individual herbal medicines continue to be licensed nationally by member states. [4]

Canada

Health Canada's licensed natural health products database includes traditional medicines such as Ayurvedic medicines, and shoppers can look for the eight-digit Natural Product Number (NPN) on the label. [5] Selling unauthorized health products is illegal in Canada, and Health Canada has warned about an Ayurvedic clinic whose products tested positive for lead and mercury. [10]

Elsewhere

The World Health Organization's 2019 global report found that, as of 2018, 124 Member States (64%) said they had laws or regulations on herbal medicines. [11] For countries not covered above, including Australia, we did not read a regulator's page this session, so check your national medicines regulator directly.

Practitioners and clinics

WHO's benchmarks for the practice of Ayurveda say practitioners and clinical establishments should obtain licensing, registration and accreditation with the appropriate regulatory body, provided such provisions are available and implemented in the country. [12] In many places, they are not. See Ayurvedic training in India and practitioners outside India.

Practical checks

• Look for a national licence or registration number where your country has one, such as the NPN in Canada.
• Treat a licence as a minimum standard, not a safety guarantee.
• Be careful with products bought on the internet: that is where the study above found metals. See buying Ayurvedic products safely.
• If something goes wrong, see reporting a problem with an Ayurvedic product.